Microbiologist II

NEVEON Executive Committee; Monroe (LA); On-site; USD 60,000 - 80,000; Full time

Job summary

Join a forward-thinking company as a Microbiologist II, where your expertise in microbiological testing and method validation will contribute to essential contamination control strategies. This role offers the opportunity to work in a collaborative environment, ensuring compliance with industry standards while developing innovative solutions. You'll be part of a team that values excellence and encourages personal growth, making a significant impact on the quality of medical devices and pharmaceuticals. If you're passionate about science and eager to make a difference, this position is perfect for you.

Qualifications

• 3+ years experience in GMP-controlled laboratory environment.
• Knowledge of medical device regulations and ISO standards.

Responsibilities

• Perform microbiological testing and method validations according to ISO standards.
• Assist in contamination control strategies and facility gowning program.

Skills

Microbiological testing

Method validation

Contamination control

Data entry and reporting

Aseptic technique training

Education

Bachelor’s Degree in Microbiology

Master’s Degree in Microbiology

Tools

SAP

Microsoft Word

Microsoft Excel

Microsoft Outlook

Job description

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Microbiologist II

Location: Monroe, US, 28110

Employment Type: Permanent

Responsibilities

1. Perform Microbiological testing and examination according to valid procedures, such as Bioburden, Endotoxin, Sterility, Growth Promotion, and Environmental Monitoring.
2. Execute method validations for medical device and non-medical device for bioburden and sterilization according to ISO standards.
3. Assist in the development and implementation of processes and facility monitoring to ensure effective contamination control strategies are established.
4. Assist in the development of facility gowning program.
5. Act as an SME for method validation for new products.
6. Author SOPs, test procedures, and assist in creating validation protocols and reports for the lab.
7. Data entry for trends and reporting on them for management review.
8. Interpretation of sterilization dose audit results and elevation of the data trends as needed.
9. Test non-conforming product to resolve QIR issues as well as investigate returned products via complaint processing system.
10. Assist in investigations along with other departments to identify root cause.
11. Completion of assigned CAPA as needed.
12. Conduct aseptic technique training and Hygiene regulation training for other departments.
13. Review and maintain stock of consumables (supplies and equipment) for Microbiology department.
14. Purchase requisition and material transfer in SAP.
15. Coordination of sample testing via external/third-party vendor(s).
16. Communication and information exchange with affiliated Greiner facilities.
17. Other duties as assigned.

Your Profile

1. Minimum Bachelor’s or Master’s Degree in microbiology, or related field.
2. Minimum 3 years of relevant work experience in GMP-controlled laboratory environment.
3. Experience in Medical Device, Pharmaceutical, and/or regulated industry is preferred.
4. Basic Knowledge of medical device regulation, industry, and international standards.
5. Basic understanding of computer systems (Word, Excel, Outlook, and instrument dedicated).
6. Knowledge of gamma and ebeam sterilization, and ISO 11137 requirements.

Physical Requirements

1. Must be able to stand and walk for up to 8 hours.
2. Must be able to lift up to 70 lbs.

As an employer, we stand for equal opportunities and all qualified applicants are considered regardless of race, religion, creed, color, sex, sexual orientation, gender identity, genetic information, age national origin, veteran status, physical or mental disability or any other characteristics protected under applicable federal, state or local law. We have set ourselves the goal of increasing the proportion of women in managerial and expert positions and therefore encourage qualified women to apply.

Job ID: 2558

For visionaries with drive and ideas, for team players who share their knowledge and entertain new ways of thinking, for people who strive for excellence. Our door is always open to achievers, doers and hidden talents who want to make a difference.